Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Purpose: Once-daily tacrolimus extended-release formulation (TACER) has been accepted in kidney transplantation, however its optimal dosing are not well determined. We have validated the institutional subgroup analysis of multi-center randomized controlled trial to optimize TACER dose with mycophenolate mofetile (MMF) .
Patients and Methods: Fifty Living-donor kidney transplant recipients were prospectively randomized into two group, 1) Low dose (LD) group (n=26) ; targeting tacrolimus area under curve profiles (TAC-AUC) 0-24 250ng[bull]hr/ml during the first 1 months and reduced to 200ng[bull]hr/ml after 3 months. 2) Very low dose (VLD) group (n=24); targeting TAC-AUC0-24 200ng[bull]hr/ml during the first 1 months and reduced to 150ng[bull]hr/ml after 3 months. All patients received MMF, corticosteroid and basiliximab induction. MMF was adjusted to achieve MPA-AUC0-12 between 30-60 [mu]g[bull]hr/L. Protocol biopsy were evaluated after 1 and 12 months. Donor specific antibody(DSA)production was also evaluated annually.
Results: With a mean observation of 31 months (16-47), patients and graft survival are 100% in both groups. Mean tacrolimus trough concentration at 1 month, 1 and 2 years after transplant was 5.5±1.8, 5.1±0.9 and 4.9±1.0 ng/ml in LD group, and 4.7±1.1, 3.1±0.6 and 3.7±0.9ng/ml in VLD group. Significant difference in tacrolimus trough level was observed from 3 months to 2 year after transplant between LD and VLD group (p<0.05). Incidence of T cell mediated rejection was similar among both group (0% in LD group and 8.3% in VLD group), while incidence of CMV infection was reduced in VLD group (16.7%) compared to LD group (30.7%) respectively. Mean eGFR were equivalent between the two groups and maintained at 48.6±10.9 and 54.2±12.8ml/min/1.73m2 in LD group and 51.2±12.1 and 51.8±12.4ml/min/1.73m2 in VLD group at 1 and 2 year after transplant. Luminex solid phase assay revealed similar incidence of DSA production in both group (0% in LD group and 8.3% in VLD group at 2 years)(P>0.05).
Conclusions: Significant reduction of tacrolimus exposure with TACER, was achieved with excellent clinical outcomes such as patient/graft survival, graft function and DSA production rate under careful AUC monitoring of tacrolimus and MPA.
CITATION INFORMATION: Watarai Y, Narumi S, Okada M, Kimura R, Hatazoe K, Futamura K, Yamamoto T, Hiramitsu T, Tsujita M, Goto N, Kobayashi T. Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetile Based Immunosuppression in De Novo Kidney Transplant Recipients: 2 Years Outcome. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:Watarai Y, Narumi S, Okada M, Kimura R, Hatazoe K, Futamura K, Yamamoto T, Hiramitsu T, Tsujita M, Goto N, Kobayashi T. Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetile Based Immunosuppression in De Novo Kidney Transplant Recipients: 2 Years Outcome. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/optimization-of-extended-release-tacrolimus-dose-with-mycophenolate-mofetile-based-immunosuppression-in-de-novo-kidney-transplant-recipients-2-years-outcome/. Accessed April 15, 2021.
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